myRIS DRUGS & BIOLOGICS
Contents
1. CMD Working Parties Working Groups Working Group on Active Substance Master File Procedures In order to facilitate the request of EU ASMF numbers a dedicated list of contact persons has been set up that will be added to the published Contact Points AcM Dh EU_ASMF_number_request_form docx e BLUE BOX REQUIREMENTS cuDh Blue Box requirements October 2013 pdf edovr European Directorate for the Quality of Medicines amp HealthCare http www edqm eu en edqm homepage 628 html amp Council of Europe s European Directorate for the Quality of Medicines and Healthcare EDQM and European Medicines Agency joint meeting on raw materials used for the production of cell based and gene therapy products TAREPORT symposium raw materials cell based and gene therapy products pdf amp Safety Data Sheets subscriptions and translations source EDQM Counterfeiting of medical products the Council of Europe steps up action worldwide with the Medicrime Convention source EDQM Certification Monthly Report of Activities Source EDQM FRANCE 13 FE D Legifrance UE senvice pusuc ous uno gt D cret no 2013 935 du 18 octobre 2013 relatif aux modalit s de d claration de certaines contributions pharmaceutiques Source LegiFrance D cret no 2013 923 du 16 octobre 2013 pris pour la transposition de la directive 2012 26 UE du 25 octobre 2012 modifiant en ce qui concerne la pharmacovigi2. Drugs amp Biologics REGULATORY INTELLIGENCE SERVICE Le webzine du cabinet White Tillet Friday November 8 2013 SW45 2013 Send a surprise gift to your friends sign them up to receive our free weekly Webzine by sending their email address to white tillet white tillet com gt SOMMAIRE NES p 2 e WORLDWIDE gt ia tatttecessteeecsstteceeesseeecs p 4 e EUROPEAN UNION p 6 FRANCE OOOO om p 13 EUROPE OOOO nananaaneneaaseneeeneneneaeseeennne p 18 RUSSIA amp RELATED COUNTRIES p 23 NORTH AMERICA aasseesssrrrsesrrrsssreressreree p 23 e LATIN AMERICA a atecessttceeesssteseseesteeeeees p 27 AFRICA eas ee tevecedtrseeececee p 28 AUSTRALIA amp NEW ZELAND aasnersrrrssrersssrerrssre p 30 e INDIA PAKISTAN amp ASIA p 31 DISCOVERY AND BUSINESS DEVELOPMENT p 35 Parmi les sujets s lectionn s dans ce num ro Johnson amp Johnson d bourse 2 2 milliards de dollars pour viter un D cret N 2013 935 du 18 10 2013 relatif aux modalit s de d claration proc s p 2 de certaines contributions pharmaceutiques p 14 Teva says it may have violated bribery laws around the world p 2 D cret N 2013 923 du 16 10 2013 pris pour la transposition de la directive 2012 26 UE du 25 10 2012 modifiant en ce qui concerne la pharmacovigilance la directive 2001 83 CE instituant un code communautaire relatif aux medicaments usage hum
3. Experts Robert Benzaki Ing SupElec S verine Francois M Sc Jocelyne Lejay ParmD PhD Clotilde Mazerolles PharmD Nadine Vincent PharmD Aurelio Zerial PhD and a panel of Experts specialized in drug and device evaluation medical amp scientific Yves TILLET MD WHITE Tel 33 0 1 600 843 85 35 rue Franck H mon F 77500 CHELLES Le Cabinet WHITE TILLET est lorsque les prestations le justifient 39 Se e E WHITE TILLET SSE Experience amp Expertise Associate Consultants amp Experts Tel 33 1 600 843 85 E mail white tillet white tillet com Website www white tillet com Pour abonner vos ami e s crire white tillet white tillet com Pour vous d sabonner crire contact wt wanadoo fr 40
4. www has sante fr portail jcms j_5 accueil FICHES DE BON USAGE source HAS SYNTHESES D AVIS SUR LES MEDICAMENTS source HAS amp Label de la HAS Troubles du Comportement chez les Traumatis s Cr niens Quelles options th rapeutiques Les troubles du comportement des victimes de traumatisme cr nien constituent la s quelle majeure chez ces bless s Les troubles du comportement ont des cons quences n fastes multiples impliquant les familles les soignants et nombre d autres professionnels magistrats avocats assureurs etc Le pr sent travail a pour objectifs e d organiser la d marche de soins dont une meilleure information des intervenants occasionnels e de fournir un guide pratique de prise en charge pour le praticien 17 e d am liorer l efficience des diff rentes modalit s th rapeutiques traitements m dicamenteux et non m dicamenteux strat gie th rapeutique hospitalisation suivi ambulatoire insertion professionnelle y compris en milieu adapt Source HAS amp Maladie d Alzheimer et maladies apparent es diagnostic et prise en charge de l apathie Note de cadrage Cette note de cadrage pr sente le projet de recommandations de bonne pratique sur le theme diagnostic et prise en charge de l apathie chez les patients atteints de maladie d Alzheimer ou de maladies apparent es qui est en cours de r alisation par la HAS Les recommandations sur la prise en charge des troubles d
5. CellforCure filiale du laboratoire pharmaceutique public LFB Source UsineNouvelle 14 Les investissements pharma s effondrent en France Voici une vol e de chiffres qui va apporter de l eau au moulin des industriels fran ais de la fili re pharmaceutique fran aise tr s remont s contre le PLFSS 2014 et la politique fiscale men e par le gouvernement qui selon eux compromettent gravement l attractivit du territoire Ainsi selon l Observatoire des investissements productifs cr par le Leem et le cluster Polepharma qui pr sentait hier ces donn es en avant premi re les investissements corporels bruts engag s en 2012 se sont lev s 590 7 ME soit une baisse de 44 en quatre ans Environ 70 de ce montant peut tre attribu cinq groupes seulement Il est temps de sonner le tocsin a soulign Pascal Le Guyader directeur des affaires g n rales industrielles et sociales du Leem l issue de cette pr sentation Il a par ailleurs estim que le solde net des emplois cr s par la fili re pourrait en 2013 tre n gatif probablement de l ordre de 1 Source ActuLabo lem LES ENTREPRISES DU MEDICAMENT Valorisation et mod lisation m dico conomique du couple Test diagnostique compagnon et Th rapie cibl e Cette contribution a pour objectif de discuter de la d marche suivre dans le cadre d une valuation m dico conomique d un couple test compagnon th
6. L bioreactors to Shanghai facility WuXi PharmaTech NYSE WX a leading pharmaceutical biotechnology and medical device research and development outsourcing company with operations in China and the United States announced today that it had completed a cell culture capacity expansion including two 2000L disposable bioreactors that are ready for cGMP manufacturing Previously WuXi AppTec had built a state of the art cGMP biologics manufacturing facility with two cell culture suites containing a 500L and a 1000L disposable bioreactor respectively As a result of this new expansion WuXi AppTec operates the largest biologics facility with disposable bioreactors in China and the largest disposable bioreactor in the world The facility has passed GMP audits from global clients and an audit by former U S FDA biologics inspectors Source FiercePharmaManufacturing HSA http www hsa gov sg publish hsaportal en home html page tab1 33 MIB CDSCO woo ccscones India s health ministry directed to re evaluate 157 clinical trials Source MedCityNews After price cuts big pharma companies focussing on brands distribution Big pharmaceutical companies profit margins may be under pressure because of a government induced fall in prices of dozens of medicines but they could end up with a larger share of the market at the expense of small and mediumsized drug firms e Given the narrowed down price differential between
7. Space Verification October 2013 pdf Amendments to the pharmacovigilance legislation new notification requirements for marketing authorisation holders and changes to scope of European safety referrals Amendments of the European Union EU pharmacovigilance legislation that were adopted in October 2012 came into force on Monday 28 October 2013 These changes which cover various aspects of the legislation aim to further strengthen the protection of patient health by increasing the ability of the European medicines network to take prompt and appropriate regulatory action Source EMA amp Meeting highlights from the Committee for Medicinal Products for Human Use CHMP 21 24 October 2013 This page provides an overview of the opinions adopted at the October 2013 meeting of the Committee for Medicinal Products for Human Use CHMP and other important outcomes Three new medicines recommended for approval This month the CHMP recommended the approval of Opsumit an orphan medicine intended for the treatment of pulmonary arterial hypertension in adults The Committee gave a positive recommendation for Brintellix in the treatment of major depressive episodes in adults The generic medicine Levetiracetam Hospira also received a positive opinion for use in epilepsy Source EMA amp EMA How access to full clinical trial data sets will benefit medicines developers Source EMA amp European Medicines Agency advises on
8. consortium The AML Cancer Panel is used for enriching the genome for regions of interest before performing NGS It can therefore be used to study disease occurrence and progression and help with the development of better targeted therapies Source CPhl Using Fluorescence Lifetime Imaging Microscopy to Monitor Theranostic Nanoparticle Uptake and Intracellular Doxorubicin Release Basuki J et Al ACS Nano Article ASAP DOI 10 1021 nn404407 Publication Date Web October 16 2013 H1299 spheroid lIONPs DOX intracellular DOX release We describe the synthesis of iron oxide nanoparticles IONPs with excellent colloidal stability in both water and serum imparted by carefully designed grafted polymer shells The polymer shells were built with attached aldehyde functionality to enable the reversible attachment of doxorubicin DOX via imine bonds providing a controlled release mechanism for DOX in acidic environments The IONPs were shown to be readily taken up by cell lines MCF 7 breast cancer cells and H1299 lung cancer cells and intracellular release of DOX was proven using in vitro fluorescence lifetime imaging microscopy FLIM measurements Using the fluorescence lifetime difference exhibited by native DOX 1 ns compared to conjugated DOX 4 6 ns the intracellular release of conjugated DOX was in situ monitored in H1299 and was estimated using phasor plot representation showing a clear increase of native DOX with tim
9. default aspx http www lakemedelsverket se english E Health system review Health system review Austria pdf FR EEE http www eum hu about us the ministry ministry of health http www swissmedic ch index html lang fr amp Fake drugs intercepted by Swiss customs source Swissinfo amp DHPC Erivedge vismodegib prolongation de 7 mois a 24 mois de la p riode pendant laquelle une contraception est recommand e apr s la fin du traitement par Erivedge chez les femmes en tat de procr er Source SWISSMEDIC Toxine botulique de type A m dicaments autoris s et indications mode d emploi correct risques et precautions Source SWISSMEDIC Les et les sont au c ur de nos pr occupations et dans notre champ de comp tence N h sitez pas venir vers nous pour Nous avons un r seau de des correspondants locaux en Asie et aux Etats Unis 22 Ministry of Healthcare of the Russian Federation http government ru eng power 23 _ Ministry of Health of Ukraine http www kmu gov ua control en publish articleP art id 88456 Health system review Health system review Belarus pdf http www fda gov amp FDA Guidance for Industry Chronic Hepatitis C Virus Infection Developing Direct Acting Antiviral Drugs for Treatment Revision 1 Source FDA amp FDA Guidance for Industry Acute Bacterial Skin and Skin Structure Infections Developing Drugs for Treat
10. fails to affect AMPAR or GABA receptors GABA Rs mediated responses Cholesterol itself and other naturally occurring oxysterols present in brain do not modulate NMDARs at concentrations lt 10 um In hippocampal slices 24 S HC enhances the ability of subthreshold stimuli to induce long term potentiation LTP 24 S HC also reverses hippocampal LTP deficits induced by the NMDAR channel blocker ketamine Finally we show that synthetic drug like derivatives of 24 S HC which potently enhance NMDAR mediated EPSCs and LTP restore behavioral and cognitive deficits in rodents treated with NMDAR channel blockers Thus 24 S HC may function as an endogenous modulator of NMDARs acting at a novel oxysterol modulatory site that also represents a target for therapeutic drug development Source TheJournalOfNeuroscience 37 amp Genetic basis of neurocognitive decline and reduced white matter integrity in normal human brain aging Glahn D et Al doi 10 1073 pnas 1313735110 PNAS November 4 2013 Identification of genes associated with brain aging should markedly improve our understanding of the biological processes that govern normal age related decline However challenges to identifying genes that facilitate successful brain aging are considerable including a lack of established phenotypes and difficulties in modeling the effects of aging per se rather than genes that influence the underlying trait In a large cohort of randomly selected pedigr
11. for treating vitreomacular traction in adults including when associated with a macular hole with a diameter of 400 micrometres or less only if they have severe symptoms and an epiretinal membrane is not present Source Nice NICE Choroidal neovascularisation pathological myopia ranibizumab final appraisal determination source NICE amp NICE Non Hodgkin s lymphoma relapsed refractory pixantrone monotherapy appraisal consultation 2 source NICE NICE rejects J amp J s Zytiga as too expensive The National Institute for Health and Clinical Excellence issued draft guidance recommending against Zytiga use saying that the drug doesn t work well enough to justify its price And that s after J amp J offered a discount to help sway the agency in its favor Source FiercePharma a pi IRISH MEDICINES HOARD http www imb ie IRISH MEDICINES BOARD GUIDE TO AMENDMENT AND RENEWAL APPLICATIONS FOR PROJECTS REGULATED BY DIRECTIVE 2010 63 EU AND S I NO 543 OF 2012 Source IMB amp IMB Guide to Interchangeable Medicines source IMB Bin amps amp Pharmacovigilance Nouvelle r glementation en mati re de mamerne http www fagg afmps be fr pharmacovigilance pour les m dicaments usage humain Source AFMPS ttp www bfarm de DE Home home_node html i E http www agenziafarmaco gov it en 21 http www aemps gob es en home htm http www legemiddelverket no English Sider
12. or after one docetaxel containing chemotherapy regimen and if the manufacturer provides it with the discount agreed in the patient access scheme PAS NICE says that its independent appraisal committee had heard that although both Xtandi and Johnson amp Johnson s prostate cancer drug Zytiga abiraterone are oral treatments only Xtandi can be taken on a full stomach making it more convenient to take The panel was also told that Xtandi can help control the cancer longer because there is no need to reduce the dose to prevent liver toxicity as with Zytiga The draft guidance has been welcomed by Prostate Cancer UK which points out that Xtandi is one of the few treatments shown to extend the lives of men with advanced prostate cancer Source PharmaTimes NICE amp NICE says yes to eye condition treatment in draft guidance NICE has published draft guidance recommending ocriplasmin Jetrea ThromboGenics as an option for treating some adults with the rare eye condition vitreomacular traction Vitreomacular traction occurs when the vitreous the gel like substance in the eye pulls abnormally on the retina the light sensitive layer of tissue at the back of the inner eye which is responsible for processing 20 visual images The pulling of the gel disturbs the retina causing swelling and distorted vision and sometimes a hole in the macular area It can occur as a result of ageing NICE has recommended ocriplasmin as an option
13. shielding glycans The structure also provides insights into trimer assembly gp120 gp41 interactions and the CD4bs epitope cluster for bnAbs which covers a more extensive area and defines a more complex site of vulnerability than previously described Source ScienceJournals amp The Major Brain Cholesterol Metabolite 24 S Hydroxycholesterol Is a Potent Allosteric Modulator of N Methyl d Aspartate Receptors Steven P et Al The Journal of Neuroscience 30 October 2013 33 44 17290 17300 doi 10 1523 JNEUROSCI 2619 13 2013 N methyl d aspartate receptors NMDARs are glutamate gated ion channels that are critical to the regulation of excitatory synaptic function in the CNS NMDARs govern experience dependent synaptic plasticity and have been implicated in the pathophysiology of various neuropsychiatric disorders including the cognitive deficits of schizophrenia and certain forms of autism Certain neurosteroids modulate NMDARs experimentally but their low potency poor selectivity and very low brain concentrations make them poor candidates as endogenous ligands or therapeutic agents Here we show that the major brain derived cholesterol metabolite 24 S hydroxycholesterol 24 S HC is a very potent direct and selective positive allosteric modulator of NMDARs with a mechanism that does not overlap that of other allosteric modulators At submicromolar concentrations 24 S HC potentiates NMDAR mediated EPSCs in rat hippocampal neurons but
14. v n neuses des produits di t tiques cosm tiques et d hygi ne dans les secteurs publics et priv s De l application des Conventions et Trait s internationaux relatifs aux stup fiants et aux substances psychotropes De la r glementation des professions de pharmacie et de laboratoires d analyses m dicales De l tablissement et de l entretien des relations avec les organisations professionnelles de pharmacie et de laboratoires d analyses m dicales De l organisation de la pharmacovigilance De l organisation de la lutte contre le trafic illicite de m dicaments stup fiants et substances psychotropes ainsi que de la participation la lutte contre la toxicomanie De la promotionet de la mise en uvre du plan de d veloppement de l industrie pharmaceutique Du secr tariat de divers commissions notamment la commission de programmation des cr ations des transferts des g rances et des ventes d officine de pharmacie et de laboratoires d analyses m dicales la commission nationale de th rapeutique la commission nationale de pharmacovigilance la commission d enregistrement des m dicaments la coordination des pays de la zone franc et les pays associ s sur la politique du m dicament 29 amp Promotion de l Industrie Pharmaceutique source DPHM amp Pharmacovigilance et Lutte contre les M dicaments Illicites source DPHM AUSTRALIA NEW ZELAND 2 Ri Australian Government SS Department o
15. were as significant as those of any other stakeholder in the healthcare process was not a standard part of this model Over the past decades this has changed as it has become increasingly clear that such a model is neither appropriate nor useful in a better connected and less deferential world The Workshop on the patient s voice in the evaluation of medicines brought together representatives of patients consumers and healthcare professionals as well as the pharmaceutical industry and members of the Agency s scientific committees and staff Action points identified included the need to identify where quantitative versus qualitative input is needed and develop and validate new tools for eliciting values and preferences and representing benefit and risk these tools need to take account of the way values vary between patients and can change during the patient journey develop means for identifying and managing differences of view among patients and between patients and other stakeholders consider what training and support is needed to maximise patient involvement at all stages of the process for the full range of disease states and who should be supplying these further develop the role and timing of patient involvement in later post marketing stages of the product lifecycle e g in signal assessment identify and try to minimise legal regulatory financial and procedural barriers to patient involvement These ac
16. MF Advices in Regulatory and Methodology Selection and Follow up of Nonclinica l and Clinical CROs Nonclini tei Nonclinical and Clinical Protocols and Study Reports CTA ORegulatory Affairs Registration Files CE Mark dossiers Medicinal Products All CTD modules e CTD CE Procedures including Chemicals Herbals Biologics Validation for Submission Combination Products Orphan Drugs Follow up of all EU procedures Relationship with all Advanced Therapies Centralized DCP MRP Nat Notified Bodies NB Medical Devices Blue box Modifications Combination Products Relationship with Regulatory Agencies Borderline Products EMA ANSM MHRA BfArM All EU member States OReimbursement National amp Common European dossiers Post Marketing Studies OFost Marketing Medicinal Information and Advertising Control OExport outside EU Advice amp Assistance o Business Development Parternship Due diligence amp Permanence Portfolio products Manufacturing Suppliers Quality Training Quality Development Regulation and Reimbursement for Medicinal Products and Medical Devices Food Supplement Cosmetics We also advice and assist clients in food supplements and cosmetics when medical purpose Contact e mail white tillet white tillet com Web site www white tillet com French Office Yves Tillet PharmD M Sc IAE AFAR FTOPRA UK Office Charisbert Owen Lewellen PhD C Chem FRSC FTOPRA Associate Consultants amp
17. ain p 14 WorldMedical Association Declaration of Helsinski Ethical Principles for Antimicrobial prescribing and stewardship competencies Medical Research involving human subjects 64 WMA General Assembly Fortaleza Brazil October 2013 p 4 FDA Summary of ICH Q3D Guideline for elemental impurities draft Following simple steps can help reduce surgical site infections saving consensus guideline p 5 lives and money says NICE in new standards p 20 New EMA guidance on development of antibacterials to help in the FDA Guidance for Industry Chronic hepatitis C virus infection fight against multidrug resistant pathogens p 8 developing direct acting antiviral drugs for treatment Revision 1 p 23 EMA Questions and answers on design space verification p 8 EMA Amendments to the pharmacovigilance legislation new TGA Biosimilar medicines information for health professionals p 30 notification requirements for marketing authorization holders and changes to scope of European safety referrals p 9 EMA First qualification opinion on a statistical methodology for dose The PMDA publishes a list of new drugs which are unapproved in Japan finding released for public consultation p 9 but approved in the USA and the EU p 32 EMA launches public catalogue of medicine shortages assessed by the China issues revised GSP for cold chain quality control p 32 Agency p 11 CMDh Regulation EC N 1234 2008 on variations p 12 India s health ministry directed to r
18. al government s Sunshine program for disclosing financial ties between industry and physicians reflects a lengthy campaign to curb marketing tactics perceived to boost inappropriate prescribing Media reports regularly attack high drug prices both for life saving specialty drugs and for widely used treatments such as asthma inhalers And recent disclosures raise questions about too close ties between pharma companies and Food and Drug Administration officials Source PharmExec Biotech research requires strong protections Recent biopharmaceutical advancements are changing the way we think about medicine Biologics are being manufactured from living cells to treat sickness at the most basic biological level These drugs are far more complex and effective than traditional chemical based medicines Texas based research centers are testing for example a virus based biologic that may someday treat melanoma as well as a sophisticated antibody that will target cancers and lupus Developing such groundbreaking treatments is neither cheap nor easy A mere five out of every 5 000 compounds devised will ever make it to clinical testing The testing process itself takes on average at least seven years And after all that only one in five drugs tested on humans will ever make it to pharmacy shelves The biologic development process is unsurprisingly extremely expensive Including the cost of drugs that fail the average cost to bri
19. alaysia MOH Philippines DOH Singapore HSA Taiwan TFDA Thailand FDA Vietnam MOH P fre Pharmaceuticals and Medical Devices Agency Japan htto Wwww pmda go ip english 31 amp The PMDA publishes a list of new drugs which are unapproved in Japan but approved in the USA and the EU The following drug types are in scope of this list USA NDA Chemical Types 1 New molecular entity NME and Biologics license application BLA EU New Active Substance NAS Medicines not approved in Japan but approved in EU or US xls B MS files first all oral interferon free HCV drug in Japan Bristol Myers Squibb Co has filed an all oral combination in Japan for hepatitis C seeking the world s first interferon and ribavirin free treatment regimen for the disease The submission with Japan s Pharmaceutical and Medical Devices Agency is for daclatasvir a NS5A inhibitor and the protease inhibitor asunaprevir It is based on results from a Phase III study demonstrating that the combo achieved an overall sustained virologic response 24 weeks after the end of treatment of 84 7 in Japanese patients Source PharmaTimes amp Bristol seeks Japan approval of all oral hepatitis C treatment The submission with Japan s Pharmaceutical and Medical Devices Agency marks the first time that any drugmaker has filed for approval of a hepatitis C treatment regimen that does not include either of the standard older treatments the injected di
20. ance to preserve these crucial treatments and to help control resistance Improving surveillance and infection prevention and control are other key strategies UK DH Antimicrobial prescribing and stewardship compentencies October 2013 pdf amp U K Drug Regulator Recalls 5 Drugs Made by India s Wockhardt source WSJ amp UK health research body backs trial data disclosure amp access to patient data source Clinica amp Information sent to healthcare professionals in October about the safety of medicines Copies of letters sent to healthcare professionals in October 2013 to inform of new safety information and advice Source MHRA amp Ten years and beyond In the last ten years the Agency expanded its offerings including e licensing decisions on whether to grant authorisations to place medicines on the market e authorisation and inspection of clinical trials of medicines e new procedures for authorising medicines intended to be marketed across Europe 19 Recently National Institute for Biological Standards and Control NIBSC join the Agency NIBSC is responsible for producing over 90 of the International Standards used to assure the quality of biological medicines Source MHRA NHS National Institute for else ee lee tele http www nice org uk Following simple steps can help reduce surgical site infections saving lives and money says NICE in new standards Surgical site infecti
21. cancer drugs Health Minister Peter Dutton says it means about 230 000 people can receive treatments they might not otherwise have been able to afford The new listings include a ground breaking treatment for melanoma skin cancer Dabrafenib sold as Rafinlar is the first melanoma medicine that targets a genetic mutation present in about half of all melanoma cases Mr Dutton says the genetic testing needed to determine eligibility for the medicine will also be subsidised benefiting more than 800 Australians Source SMH 30 Role of the Advisory Committee on Prescription Medicines ACPM in the TGA s regulatory decision making process source TGA TGA presentations given at the complementary medicines road shows July August 2013 source TGA DSM opens Australia biologics plant The contract manufacturing arm of the Dutch based Royal DSM officially opened the 65 million facility Wednesday The first custom mammalian based biopharmaceutical manufacturing facility in Australia it is a pet project of Australia s 345 million Translational Research Institute which is being built to attract medical research to Australia The Dutch company has gotten support from the governments of Queensland and the Commonwealth to build the plant Source FiercePharmaManufacturing A N ZT PA http www anztpa org INDIA PAKISTAN amp ASIA China SFDA Hong Kong MDCO amp PSDH India CDSCO Japan MHLW Korea KFDA M
22. compassionate use of sofosbuvir Source EMA amp First qualification opinion on a statistical methodology for dose finding released for public consultation source EMA amp EMA Revised reflection paper on injection site residues considerations for risk assessment and residue surveillance Draft source EMA amp Concept paper on the revision of the Note for guidance on the approach towards harmonisation of withdrawal periods source EMA Comments invited on concept paper on the need to revise the guideline on medicines to treat Alzheimer s disease The European Medicines Agency has released a concept paper on the need to revise the guideline on medicines for the treatment of Alzheimer s disease and other dementias for public consultation Comments should be sent by 31 January 2014 to cnswpsecretariat ema europa eu using the template provided Source EMA amp The patient s voice in the evaluation of medicines How patients can contribute to assessment of benefit and risk The ultimate raison d tre of any medicine is to benefit patients However older and more paternalistic models of medicine often treated patients as a passive group who were to be given instructions but who should not be confused or worried by too much information Although the best healthcare professionals have always recognised the importance of listening carefully to their patients the idea that patients knowledge views and preferences
23. could face fines lawsuits and criminal actions It said it turned all of the information over to the Securities and Exchange Commission SEC and the Department of Justice in the U S Source FiercePharma Scientists voice fears over ethics of drug trials remaining unpublished Drug companies and other organisations that carry out clinical trials are violating their ethical obligation to the people who take part by failing to publish the results scientists will argue on Wednesday Almost one in three 29 large clinical trials in the United States remain unpublished five years after they are finished according to scientists writing in the British Medical Journal Of those 78 have no results at all in the public domain The scientists calculate about 250 000 people took part in the unpublished trials and have therefore been exposed to all the risks involved in research without the benefits to society they were led to believe would ensue This violates an ethical obligation that investigators have towards study participants say Christopher Jones from the Department of Emergency Medicine Cooper Medical School of Rowan University New Jersey and colleagues They call for additional safeguards to ensure timely public dissemination of trial data Source TheGuardian amp Merck s Experimental HPV Vaccine Shows Promise in Late Stage Trial Source WSJ amp AstraZeneca s asthma drug benralizumab advances in Phase Il
24. cs In its petition the company also highlights that assigning different INNs to biosimilars would introduce unnecessary confusion into the healthcare system and could unintentionally communicate increased caution unfounded risk or other regulatory reservations that are purely hypothetical Source PMPNews J amp J s Zytiga gets expanded approval that could double sales The FDA on Monday said it approved Zytiga for treatment in men with late stage prostate cancer even before they receive chemotherapy A study found that it reduced tumor growth and could extend life expectancy about 5 months Source FiercePharma amp FDA approves Roche leukemia drug Gazyva U S regulators said on Friday they approved a new treatment from Roche Holding AG for patients with chronic lymphocytic leukemia CLL who have not previously been treated for one of the most common forms of blood cancer Source Reuters 25 i i OS EE DEE 1 A FT a ET USA BIO calls for different names for biosimilars branded biotech drugs Like their pharmaceutical counterparts branded biotech drugs carry both a brand name and a generic chemical name such as the autoimmune drug Enbrel made by Amgen and Pfizer known generically as etanercept By law generic pharmaceutical drugs are chemically identical to branded drugs and use the same generic names and the companies wishing to make follow on biologics or biosimilars wan
25. d at the Liver Meeting in Washington DC evaluated faldaprevir in combination with pegylated interferon and ribavirin in treatment naive and experienced patients as well as in HIV co infected participants Among the highlights of the data in the STARTVerso 1 and 2 trials 84 of treatment naive patients receiving faldaprevir were able to shorten the total time on treatment from 48 to 24 weeks and 83 of these patients achieved viral cure SVR12 Interim results from STARTVerso 4 showed that 74 of patients with HCV HIV co infection had undetectable HCV four weeks after the conclusion of treatment Source PharmaTimes 38 in WAITE TILLET Expenence amp Expertise The Cabinet WHITE TILLET consists in an Associate Senior panel of Experts and Consultants French and British whose experience and expertise can offer a wide range of multidisciplinary Industrial Health Services in quality development regulatory affairs registration reimbursement and business development The Cabinet WHITE TILLET is also access to an international network composed of professionals in Regulatory Affairs selected experienced as reliable sources of information advice and assistance in the world PROFESSIONAL SERVICES MEDICINAL PRODUCTS MEDICAL DEVICES GMP Partie 1 amp 2 ISO 9001 1SO 13485 Audit Quality Assurance Quality Management GLP GCP Audit Systems implementation Development Pharmaceutical Technical Development Plans AS
26. drug delivery treatment of cancer cells The first of its kind nanostructure is unusual because it can carry a variety of cancer fighting materials on its double sided Janus surface and within its porous interior Because of its unique structure the nano carrier can do all of the following e Transport cancer specific detection nanoparticles and biomarkers to a site within the body e g the breast or the prostate This promises earlier diagnosis than is possible with today s tools e Attach fluorescent marker materials to illuminate specific cancer cells so that they are easier to locate and find for treatment whether drug delivery or surgery 35 e Deliver anti cancer drugs for pinpoint targeted treatment of cancer cells which should result in few drug side effects Currently a cancer treatment like chemotherapy affects not only cancer cells but healthy cells as well leading to serious and often debilitating side effects Source University of Cincinnati amp Integrated DNA Technologies Launches its First Cancer Panel Integrated DNA Technologies IDT is enabling cancer research with its latest next generation sequencing NGS product the xGen Acute Myeloid Leukemia Cancer Panel v1 0 Consisting of 11 743 xGen Lockdown Probes this cancer panel targets more than 260 clinically relevant genes that were found to be mutated in a study of 200 patients with acute myeloid leukemia AML and published by The Cancer Genome Atlas
27. drug maker Bristol Myers Squibb s anticancer drug Dasatinib sold under the brand name Sprycel The ruling comes after India last year issued its first compulsory licence to Natco Pharma to manufacture the generic version of German drug maker Bayer s kidney cancer drug Nexavar Source EconomicTimes RESEARCH amp DISCOVERY BUSINESS DEVELOPMENT amp Drug Development Lags for Neglected Diseases A new study published in The Lancet Global Health highlights what its authors call a fatal imbalance in research and development of treatments for the world s poorest patients The authors acknowledge that pharmaceutical and biotechnology companies have little financial incentive to invest R amp D funds in finding treatments or cures for neglected diseases and point to a failure of public policy to encourage them They conclude Despite substantial political attention towards the burden of neglected diseases we detected no evidence of a substantial improvement in research and development activity compared with previous decades Source VOA amp UC Develops Unique Nano Carrier to Target Drug Delivery to Cancer Cells Antibody tumor specific ligand Anti cancer drug Magnebc nanoparticies Fluorescent materials Pholodynamc sensitizer A unique nanostructure developed by a team of international researchers including those at the University of Cincinnati promises improved all in one detection diagnoses and
28. e The results obtained from FLIM were corroborated using confocal microscopy clearly showing DOX accumulation in the nuclei The IONPs were also assessed as MRI negative contrast agents We observed a significant change in the transverse relaxivity properties of the IONPs going from 220 to 390 mM s_ in the presence or absence of conjugated DOX This dependence of MRI signal on IONP DOX water interactions may be exploited in future theranostic applications The in vitro studies were then extended to monitor cell uptake of the DOX loaded IONPs IONP P HBA b P OEGA DOX into two 3D multicellular tumor spheroids MCS grown 36 from two independent cell lines MCF 7 and H1299 using multiphoton excitation microscopy Source ACS amp Cryo EM Structure of a Fully Glycosylated Soluble Cleaved HIV 1 Envelope Trimer Lyumkis D et Al Science DOI 10 1126 science 1245627 The HIV 1 envelope glycoprotein Env trimer contains the receptor binding sites and membrane fusion machinery that introduce the viral genome into the host cell As the only target for broadly neutralizing antibodies bnAbs Env is a focus for rational vaccine design We present a cryo electron microscopy reconstruction and structural model of a cleaved soluble SOSIP gp140 trimer in complex with a CD4 binding site CD4bs bnAb PGVO4 at 5 8 A resolution The structure reveals the spatial arrangement of Env components including the V1 V2 V3 HR1 and HR2 domains and
29. e evaluate 157 clinical trials p 34 Beyond words the world Adrien Tillet NEWS amp Johnson amp Johnson d bourse 2 2 milliards de dollars pour viter un proces Le groupe pharmaceutique am ricain tait accus d avoir vers des pots de vin a des pharmaciens Un accord a t conclu avec le gouvernement am ricain pour mettre fin aux accusations Les accusations concernent la promotion pour des usages non approuv s comme s rs et efficaces par l autorit am ricaine des m dicaments FDA et le paiement de pots de vin a des pharmaciens et des m decins pour la vente pour ces indications des m dicaments Risperdal Invega et Natrecor d taille le communiqu Le comportement incrimin dans cette affaire a mis en p ril la sant et la s curit des patients fait valoir le ministre am ricain de la Justice Eric Holder Source LesEchos Teva says it may have violated bribery laws around the world While other countries are scrambling to understand if they have exposure to a Chinese probe into bribery Teva Pharmaceutical Industries STEVA says it has found it has similar issues elsewhere The Israeli drugmaker said in a securities filing that its own investigation has turned up suspect practices in Latin America Eastern Europe and Russia Teva reported in its quarterly report Thursday that it may have violated the U S Foreign Corrupt Practices Act FCPA and perhaps local laws and
30. edicine in health care systems Source EC amp Janssen files EMA marketing authorisation application for blood cancer medicine Ibrutinib Janssen Cilag Janssen a subsidiary of Johnson amp Johnson pharmaceutical firm has submitted marketing authorization application MAA to the European Medicines Agency EMA for the approval of once daily oral drug ibrutinib for the treatment of two forms of blood cancer The approval is intended to treat adult patients with relapsed or refractory chronic lymphocytic leukemia CLL small lymphocytic leukemia SLL and or relapsed or refractory mantle cell lymphoma MCL The company claims that ibrutinib is the first in a class of medicines called Bruton s tyrosine kinase BTK inhibitors According to the company ibrutinib covalently bonds to BTK in malignant B cells shutting down major proliferation and survival pathways Source PBR amp Baxter files application to market hemophilia B vaccine Rixubis in Europe Baxter has submitted a marketing authorization application MAA to the European Medicines Agency EMA for approval of Rixubis recombinant factor IX for the treatment and prophylaxis of bleeding in patients of all ages with hemophilia B Hemophilia B is the second most common type of haemophilia and results from insufficient amounts of clotting factor IX a naturally occurring protein in blood that helps to control bleeding The submission is based on results of researc
31. ees n 1 129 subjects we documented profound aging effects from young adulthood to old age 18 83 y on neurocognitive ability and diffusion based white matter measures Despite significant phenotypic correlation between white matter integrity and tests of processing speed working memory declarative memory and intelligence no evidence for pleiotropy between these classes of phenotypes was observed Applying an advanced quantitative gene by environment interaction analysis where age is treated as an environmental factor we demonstrate a heritable basis for neurocognitive deterioration as a function of age Furthermore by decomposing gene by aging G x A interactions we infer that different genes influence some neurocognitive traits as a function of age whereas other neurocognitive traits are influenced by the same genes but to differential levels from young adulthood to old age In contrast increasing white matter incoherence with age appears to be nongenetic These results clearly demonstrate that traits sensitive to the genetic influences on brain aging can be identified a critical first step in delineating the biological mechanisms of successful aging Source PNAS BI HCV drug faldaprevir shows promise Boehringer Ingelheim has presented new data from a Phase Ill trial programme which shows that faldaprevir was highly effective in a broad range of patients with genotype 1 hepatitis C The study the data from which were presente
32. en mati re de transparence d ind pendance d information et de surveillance des m dicaments Source ANSM Contactez nous pour le reviewing de vos documents publicitaires ou promotionnels amp Valdoxan agom latine Ajout d une nouvelle contre indication et rappel sur l importance de la surveillance de la fonction h patique Point d information source ANSM amp Caustinerf Arsenical et Yranicid Arsenical p tes pour usage dentaire un signal de g notoxicit est susceptible de remettre en cause le rapport b n fice risque de ces sp cialit s Point d information source 16 ANSM Ce qu il faut savoir avant de commencer un traitement par isotr tinoine orale Source ANSM Sp cialit s base de fer pour injection intraveineuse une utilisation r serv e aux tablissements de sant en raison du risque de r actions graves d hypersensibilite Point d information source ANSM D clarer un effet ind sirable quoi de neuf pour les professionnels de sant et les patients Point d Information source ANSM Le Cabinet WHITE TILLET a plus de 20 ans d exp rience et d expertise dans le domaine des dossiers d AMM Nous maitrisons l eCTD Par notre structure et notre r seau cabinet associ au UK r seau international nous maitrisons les proc dures et assurons un suivi efficace Confiez nous vos dossiers d AMM ou de variations HAS HAUTE AUTORITE DE SANT http
33. f Health and Ageing Therapeutic Goods Admmustraton http tga gov au Biosimilar medicines information for health professionals source TGA Consultation Invitation for public comment ACCS and joint ACCS ACMS meetings November 2013 source TGA amp Macutec Stiltec Pty Ltd Complaint No 2011 11 017 Background Regulation 9 of the Therapeutic Goods Regulations 1990 the Regulations permits the Secretary of the Department of Health the Secretary or her delegate to order a person such as the advertiser of therapeutic goods to undertake certain actions related to the advertising of therapeutic goods Such an order can only be made on the recommendation of the Complaints Resolution Panel the Panel which is a statutory committee that examines complaints about advertisements for therapeutic goods On 21 August 2013 the TGA delegate of the Secretary the Delegate made an order in relation to Stiltec Pty Ltd about an internet advertisement at www macutec com au regarding the product Macutec The order was made following a recommendation by the Panel on 15 August 2012 in relation to a complaint No 2011 11 017 made on 22 November 2011 The recommendation was made because Stiltec Pty Ltd had not fully complied with the Panel s determination issued on 15 June 2012 Source TGA amp Fifty new drugs listed on PBS Fifty new and amended medicines have been added to the Pharmaceutical Benefits Scheme PBS including
34. fficult to tolerate interferon or ribavirin a pill Source Reuters Ci DA China Food and Drug Administration http eng sfda gov cn WS03 CL0755 amp China Issues Revised GSP for Cold Chain Quality Control Source SFDA amp CFDA Releases New Rules Governing Regulatory Process source SFDA amp GSK s Chinese executives but not company likely to face charges in China sources Chinese police investigating allegations of widespread corrupt practices at GlaxoSmithKline Plc GSK are likely to charge some of its Chinese executives but not the British drugmaker itself legal and industry sources said Source Reuters Food and Drug Administration Department of Health http www taiwan gov tw ct asp exltem 25613 amp ctNode 1970 amp mp 1001 32 Samsung BioLogics signe un partenariat de fabrication strat gique avec Roche Samsung BioLogics a annonc aujourd hui la signature d un accord de fabrication strat gique long terme entre Samsung BioLogics et F Hoffmann La Roche Les termes de cet accord pr voient la fabrication par Samsung des m dicaments biologiques commerciaux et exclusifs de Roche dans ses deux installations de fabrication situ es a Incheon en Cor e du Sud dont l une est en construction Les conditions de l entente y compris les modalit s financi res et les produits qui seront fabriqu s ne seront pas d voil es Source PRnewswire amp WuxXi adds two 2000
35. h with hemophilia B patients previously treated with other therapies and is further supported by data secured from a study of 23 hemophilia B patients less than 12 years old Source PBR eunethta EUnetHTA strengthens its position as the scientific and technical cooperation on HTA in Europe source EUnetHTA European Medicines Agency htto www ema europa eu ema Human medicines Regulatory http www ema europa eu ema index jsp curl pages regulation landing human medicines regulatory js p amp mid WCOb01ac058001ff89 amp New EMA guidance on development of antibacterials to help in the fight against multidrug resistant pathogens The European Medicines Agency EMA today released an Addendum to the guideline on the evaluation of medicinal products indicated for the treatment of bacterial infections One of the most important aspects of the addendum is that it outlines a new approach facilitating the development of antibacterial agents targeted against multidrug resistant MDR pathogens where patients have very limited or no remaining treatment options It also gives guidance on data gathering strategies to support the benefit risk evaluation as part of the marketing authorisation process for different indications This addendum complements the Guideline on evaluation of medicinal products indicated for treatment of bacterial infections Source EMA Questions and Answers on Design Space Verification Haga Design
36. icrobial resistance Antimicrobial stewardship is an important element of the UK five year antimicrobial resistance strategy 1 and the Chief Medical Officer s annual report 2 Antimicrobial resistance is a global public health issue driven by the overuse of antimicrobials and inappropriate prescribing The increase in resistance is making antimicrobial agents less effective and contributing to infections that are hard to treat The number of infections due to multi drug resistant organisms is growing however the number of new antibiotics in the pieline is extremely limited Antimicrobial stewardship initiatives aim to improve the prescribing of all agents whether they target bacterial viral fungal mycobacterial or protozal infections Antibiotic resistance is of particular threat to children older people and those with weakened immune systems Effective antibiotics have revolutionised many treatments such as those for cancer allowing more aggressive therapy to be used and consequently leading to higher survival rates Nevertheless an increase in infections that are more difficult to treat with antibiotics affects everyone not just vulnerable groups Bacterial resistance potentially complicates the management of every infection no matter how mild they may be at the time of first presentation Educating the public and clinicians in the prudent use of antimicrobials as part of an antimicrobial stewardship programme is of paramount import
37. ing authorisations granted via MRP DCP as well as purely national marketing authorisations or a mixture of MRP DCP and purely national marketing authorisations a purely national marketing authorisation held by the same marketing authorisation holder in more than one Member State In these cases the competent authority of a Member State concerned chosen by the Coordination Group shall be the reference authority In case the worksharing procedure only contains products with the same RMS there is no need for the CMDh to choose the reference authority see section 4 Worksharing of MR DC procedures with the same RMS 12 cuMDh BEST PRACTICE GUIDE ON WORKSHARING Chapter 7 October 2013 track changes pdf amp Pilot on work sharing procedure for the assessment of Active Substance Master Files ASMF The working group on Active Substance Master File procedures is actively preparing for the start of the pilot on work sharing procedure for the assessment of ASMF A meeting with representatives of Interested Parties has been organised in the margin of the CMDh meeting in order to discuss the pilot The objective of the meeting was to present to Industry the procedures for request of an EU ASMF reference number and submissions of a new ASMF and to answer questions from Interested Parties Companies wishing to participate in the pilot will have to fill in the EU AMSF number request form that will be published on the CMDh website under
38. ion as orphan medicinal products and on the transfer of designations from one sponsor to another ENTR 6283 00 Rev 4 12 June 2013 and Annex Application Form for Orphan Medicinal Product Designation Source EC Hoffman La Roche Submission of comments on Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another ENTR 6283 00 Rev 4 Source EC Novartis EC SHIRE Commission Europ enne Que signifie le triangle noir L Union europ enne UE a mis en place un nouveau moyen d identifier les m dicaments faisant l objet d une surveillance particuli rement troite Source EC Use of omics technologies in the development of personalised medicine Under the heading Towards more personalised medicines in its Communication1 of 10 December 2008 on a Renewed Vision for the Pharmaceutical Sector the Commission announced a report on the use of omics technologies2 in pharmaceutical research and development This report presented in the form of a staff working document focuses on the potential and issues with the use of omics technologies in the research and development of personalised medicine and current EU research funding in the area recent developments in EU legislation for placing medicinal products and medical devices on the market factors affecting the uptake of personalised m
39. l clinical trial AstraZeneca has started the Phase III Windward program of its biotech drug benralizumab for the treatment of patients with severe asthma Medimmune the company s biologics research and development R amp D unit is responsible for developing benralizumab a monoclonal antibody binding to the interleukin 5 receptor IL SRa that reduces eosinophils Eosinophils are a type of white blood cells which play a major role in the cause and extremity of asthma and its side effects According to the company in patients with elevated eosinophil counts treatment with an IL 5 inhibitor in addition to guideline based strategies might improve their asthma control and decrease the frequency of asthma attacks Source PBR WORLDWIDE Government and Regulatory Bodies htto WWww pharmweb net pwmirror pwk pharmwebk html World Health Organization http www who int en amp WorldMedical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects 64th WMA General Assembly Fortaleza Brazil October 2013 World Medical Association Declaration of Helsinki 2013 pdf amp Pharma s Transparency Troubles It seems like open season on the pharmaceutical industry Academics and consumer activists charge pharma companies with hiding clinical trial information on medical product safety fueling the campaign to ul expand public access to confidential research information The feder
40. lance la directive 2001 83 CE instituant un code communautaire relatif aux m dicaments usage humain source LegiFrance Vente l unit des antibiotiques L Assembl e nationale a autoris dans le cadre du projet de loi de financement de la S curit sociale 2014 des exp rimentations de vente l unit des antibiotiques lorsque leur forme le permet Un d cret fixera les conditions d exp rimentations qui dureront trois ans Source Assemblee nationale amp Andr Choulika chef du plan industriel sur les biotechs mise tout sur la th rapie cellulaire Pour ce pragmatique pas question de multiplier les r unionites Il a profit du dernier conseil d administration de France Biotech pour arbitrer Sachant qu il n y a pas beaucoup d argent mis sur la table et que cela doit tre un projet industriel pas une usine gaz nous nous sommes concentr s sur un seule th matique confie Andr Choulika Les traitements issus de la biologie de synth se ont t cart s au profit de la th rapie cellulaire Un domaine mergent des biotechnologies qui constitue un vrai saut quantique pouvoir corriger d embl e la cellule du patient plut t que lui donner un traitement palliatif estime Patrick Biecheler associ en charge de la sant au cabinet Roland Berger Dans lequel la France voit se structurer un centre d excellence avec la plateforme de production unique en Europe inaugur e en septembre par
41. le de s curit du m dicament P des produits de sant http ansm sante fr ANSM Vigilances Mise en place de la nouvelle l gislation en pharmacovigilance quel bilan un an apr s Source ANSM Textes publi s en 2013 concernant les m dicaments M dicaments m dicaments combin s de th rapie innovante pr parations magistrales hospitali res officinales APSI allerg nes pr par s sp cialement pour un individu substances stup fiantes psychotropes ou autres substances v n neuses insecticides acaricides et antiparasitaires usage humain huiles essentielles plantes m dicinales mati res premi res a usage pharmaceutiques pharmacop e Source ANSM amp L ANSM a r uni tous ses agents pour pr parer Vavenir Point d information L Agence nationale de s curit du m dicament et des produits de sant a rassembl le 15 octobre 2013 l ensemble de ses agents pour une journ e de partage et d changes plus d un an apr s sa mise en place et 20 ans apr s la cr ation de la premi re agence du m dicament Apr s une matin e r serv e aux collaborateurs internes qui a permis de dresser un premier point d tape sur les nouveaux modes de fonctionnement de l agence et sur sa strat gie d action pour r pondre aux enjeux qui lui ont t assign s l Agence a accueilli l apr s midi des acteurs de la sant qui ont fait part de leur analyse et de leur vision sur les volutions en cours
42. ment source FDA FDA Guidance for Industry Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 14 Bacterial Endotoxins Test General Chapter source FDA 23 FDA DRAFT CONSENSUS GUIDELINE GUIDELINE FOR ELEMENTAL IMPURITIES Q3D Source FDA amp Draft Guidance on Iron Sucrose TAFDA Draft Guidance on Iron Sucrose pdf amp FDA approves extended release single entity hydrocodone product Source FDA Statement on Proposed Hydrocodone Reclassification from Janet Woodcock M D Director Center for Drug Evaluation and Research Source FDA FDA to complete phase out of chlorofluorocarbon inhalers source FDA amp FDA awards 15 grants to stimulate drug device development for rare diseases Source FDA FDA Draft Guidance for Industry Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells Tissues and Cellular and Tissue Based Products HCT Ps source FDA FDA Report Outlines Approach to Personalized Medicine The report Paving the Way for Personalized Medicine FDA s Role in a New Era of Medical Product Development outlines the fundamental ways in which the FDA has modified its traditional approaches to drug and device regulation in the new era of products that are tailored toward specific patient subtypes rather than broad diagnostic groups We re very very excited about this report because think it cap
43. n adindan Gep fee Min fie Moml al Bespin htto www hma eu cmdh html WHAT S NEW http www hma eu 186 html Regulation EC No 1234 2008 on variations The CMDh has adopted a new version of Chapter 7 work sharing of the CMDh Best Practice Guide for the submission and processing of variations in the mutual recognition procedure The document was updated to clarify that all Member States as proposed by the MAH for work sharing procedures for purely national marketing authorisations should accept the submission of the variation application if the work sharing fulfils the requirements for a work sharing procedure The revised Chapter 7 will be published on the CMDh website under Procedural Guidance Variation The CMDh has revised the Questions amp Answers on variation Questions No 3 10 on deletion of a pharmaceutical form or strength and No 4 15 on the introduction or update of the summary of the pharmacovigilance system and change in the QPPV have been amended for clarification purpose revised Questions amp Answers document will be published on the CMDh website under Questions and Answers Variations CMDh Q amp A Submission of variations Oct 2013 pdf amp CMDh BEST PRACTICE GUIDE ON WORKSHARING This guidance covers worksharing procedures for a group of products from the same marketing authorisation holder1 where none of the marketing authorisations is a centralised marketing authorisation It may include market
44. ng a new drug to market is 1 2 billion In 2011 alone the biotechnology sector spent 49 5 billion in research and development Source MySA Risk based supply chain management means more audits for excipient firms Regulatory pressure for risk based supply chain management is increasing excipient suppliers audit burden according to the team preparing to launch the excipact certification scheme as an independent association The comments came from European Fine Chemicals Group EFCG vice chairman Frithjof Holtz head of advocacy at Merck Millipore who told attendees at CPhI in Frankfurt Germany last week the economic burden extra audits places on suppliers and excipient users should not be underestimated There are increasing expectations from regulators on ensuring the safety of the supply chain means more physical audits of manufacturers suppliers and also distributors warehouses forwarders and so on He cited in Europe the FMD which requires risk assessment for appropriate good manufacturing practices for excipients and moves to revise GMPs and in the US FDASIA s supplier registration requirement as examples of regulatory moves that have increased the audit burden Source In Pharma amp Vaccines Do Not Cover Most Common HPV Types in Black Women The HPV subtypes that are most common in black women in the United States are not targeted by the currently available vaccines Gardasil and Cer
45. on is a type of healthcare associated infection in which a surgical incision site becomes infected after a surgical procedure Surgical site infections have been shown to account for up to 16 of all healthcare associated infections The rate of surgical site infection varies depending on the type of procedure with rates of over 10 for large bowel surgery and less than 1 for orthopaedic procedures Surgical site infections can often be prevented with appropriate care before during and after surgery If an infection does develop the correct treatment will minimise complications resulting from the infection The NICE quality standard is based on the NICE guidance on both surgical site infection and healthcare associated infections Source NICE amp NICE draft yes for Astellas prostate cancer drug The National Institute for Health and Care Excellence NICE has issued draft guidance recommending Astellas Pharma s Xtandi enzalutamide for treating hormone relapsed metastatic prostate cancer Xtandi is an effective treatment and as it can be taken orally it allows patients to be treated at home said Professor Carole Longson director of NICE s Centre for Health Technology Evaluation Xtandi works in a different way to other drugs currently available for prostate cancer treatment NICE s draft guidance recommends it as an option for treating hormone relapsed prostate cancer in adults only if their disease has progressed during
46. rapie cibl e en abordant les points m thodologiques cl s consid rer dans ce type d analyse Ce travail s est structur autour d une analyse des donn es de la litt rature et de la pr sentation d un mod le conceptuel envisageable dans le cas d une th rapie cibl e anti canc reuse et de son test compagnon pr dictif de la r ponse au traitement Bien que la canc rologie constitue le principal champ de r flexion de ce travail au travers des exemples cit s et du cas d tude les couple s test s compagnon s th rapie s cibl e s et plus largement la m decine personnalis e repr sentent un enjeu commun de nombreuses aires th rapeutiques Source Leem amp LEEM Fiscalit des entreprises du m dicament La France accro t son d crochage avec les autres pays europ ens Source LEEM Les contrats commerciaux liant les industriels du g n rique et les officines plus transparents Un article du projet de loi de financement de la S curit sociale PLFSS pour 2014 pr voit d imposer aux industriels de d clarer les avantages commerciaux et financiers accord s aux pharmaciens Source Daso Sant Quand les applications lectroniques e apps sont elles des Dispositifs M dicaux Le Cabinet WHITE TILLET est sp cialiste de la question et peut vous aider y r pondre le cas ch ant nous pouvons vous assister pour le marquage CE de votre application 15 ANS fred nationa
47. rotection Source HC SC amp CADTH High Sensitivity Cardiac Troponin for the Rapid Diagnosis of Acute Coronary Syndrome in the Emergency Department source CADTH LATIN AMERICA amp SSA http www salud gob mx Faes Farma sets up JV in Mexico Spain s Faes Farma is looking to expand in Latin America by setting up a joint venture with Mexico s Laboratorios Senosiain The 50 50 JV will be called MIT Farma and is an extension of the companies 15 year relationship which has seen Senosiain sell the Bilbao based firm s vasoproective product hidrosmine Faes says we are convinced that Senosiain is the best possible partner in Mexico where it is the leading domestic pharmaceutical company and the fifth biggest drugmaker including multinationals Source PharmaTimes e National Health Fr Surveillance Agency tty portal anvisa gov br wps portal anvisa home 27 Anvisa Sees Sectoral Agreements as New Form of Regulation source ANVISA RPT Brazil to produce measles rubella vaccine for poor countries Brazil s top biomedical research and development center announced plans on Monday to produce a combined measles and rubella vaccine for developing countries mainly in Africa The first Brazilian vaccine developed specifically for export will be made by Bio Manguinhos a unit of the Oswaldo Cruz Foundation Fiocruz in partnership with the Bill amp Melinda Gates Foundation Source Re
48. stantial sales up for grabs But what if generics makers had some help and an expedited review process from the FDA According to Leerink Swann analyst Jason Gerberry that s exactly what s in the works At this week s Generic Pharmaceutical Association GPhA conference the agency announced plans to aim for a 10 month review on copies of complex drugs like Advair It also said it s working with those companies looking to produce a rival to make sure they re on the right track Source FiercePharma amp Novartis Group calls on FDA to maintain the well established naming policy for all biologics to help ensure patient safety Novartis announced today it has filed a Citizen Petition with the US Food and Drug Administration FDA urging the Agency to require that a biosimilar share the same INN as the reference product Novartis files Citizen Petition with FDA urging uniform approach to use of international nonproprietary names INN for all biologic medicines A modified INN for biosimilars would impede their ability to compete fairly in the marketplace create confusion and limit patient access to these critical medicines Novartis is confident in the FDA s ability to ensure safety and efficacy of all biologics including biosimilars through its well established review process Novartis argues that changing the well established convention that the INN describe the active ingredient would undermine the safe and rational use of all biologi
49. such as the need to switch to an alternative treatment and the setting up of priority access programs The creation of this catalogue is part of an implementation plan developed by the Agency in 2012 to help the European medicines regulatory network deal with medicine supply shortages following manufacturing problems This short and medium term plan includes a number of actions that aim to prevent mitigate and manage shortages of medicines As part of these planned actions the Agency held a workshop on the prevention of medicine shortages due to manufacturing and quality problems in October 2013 The workshop aimed to discuss how to improve existing risk management strategies and how to mitigate the impact of shortages A workshop report will be published shortly amp European Medicines Agency meeting and holiday dates 2013 source EMA amp European Medicines Agency s Management Board supports plan to publish agendas and minutes of all committees source EMA 11 amp Nomination au Comite des m dicaments usage humain de l Agence europ enne des m dicaments Le Dr Pierre Demolis directeur de la direction des m dicaments en oncologie h matologie immunologie n phrologie de lANSM membre du CHMP depuis 2007 a t lu la vice pr sidence du Comit des m dicaments usage humain de l Agence europ enne des m dicaments EMA pour une dur e de 3 ans HERBAL MEDICINES FOR HUMAN USE E aly CMDh Congdo
50. t the same policy for their products But biotech companies say that because biosimilars are made from different cell lines from branded biologics they are only similar rather than identical and thus their generic names should be different such as Carrying a prefix Source DrugStoreNews cor http www pcor1 org PCORI Launches Community Building Pipeline to Proposal Awards Source PCORI amp Harold Sox MD to Serve as Senior Adviser to Patient Centered Outcomes Research Institute Source PCORI PCORI and AHRQ Partner on Request for Applications to Study Treatments for Uterine Fibroids source PCORI AHRQ Agency for Healthcare Research and Quality Advancing Excellence in Health Care http www ahrq gov amp AHRQ Letters of Intent Due November 15 for Uterine Fibroid Project Source AHRQ Ja INSTITUTE OF MEDICINE 4 OF THE NATIONAL ACADEMIES http www iom edu 26 ST SANTE HEALTH CANADA http www hc sc gc ca index fra php tabs1 3 amp TPD Guidance Document Acetylsalicylic Acid Labelling Standard Source HC SC amp Health Canada is pleased to announce the release of the revised Post Notice of Compliance NOC Changes Quality Guidance source Hc sc amp CADTH CDR Update Issue 95 source CADTH amp Health Canada Therapeutic Products Directorate Statistical Report 2012 2013 for the Patented Medicines Notice of Compliance Regulations and Data P
51. the prices of their drugs and those of small and medium firms big pharmaceutical companies are now focussing on their brands and strengthening their distribution setup Source TheEconomicTimes amp Department of Pharmaceuticals rejects drug price review pleas of DRL Abbott The Department of Pharmaceuticals has rejected a review petition filed by leading drug makers including Dr Reddy s Laboratories DRL and Abbott Healthcare on ceiling of prices on their products While Abbott Healthcare filed the petition against the fixing of ceiling price of its Phenobabitone tablets 60mg and 30 mg and Promethazine Injection 25mg ml DRL opposed fixing of the ceiling price of Omeprazole 20 mg capsules Source TheEconomicsTimes amp India slaps 787 per tn anti dumping duty on Chinese paracetamol India has imposed anti dumping duty of 787 per tonne on import of Paracetamol a widely used medicine from China for five years to protect interest of domestic players from the cheap shipments The anti dumping duty imposed on Paracetamol under this notification shall be effective for a period of five years said the Central Board of Excise and Customs CBEC in the Revenue Department Source EconomicTimes 34 amp Patent office rejects BDR Pharma s compulsory licensing application The Patent Office rejected the compulsory licensing application of Mumbai based BDR Pharmaceuticals to make a generic version of US
52. tion points will be considered as part of the on going review of the existing formal framework of interaction between the Agency and patient and consumer organisations This framework has been in place since 2005 and defines how the Agency interacts with patients and consumers EMA Report The patient s voice in the evaluation of medicines 180ct2013 pdf 10 amp European Medicines Agency launches public catalogue of medicine shortages assessed by the Agency The European Medicines Agency has launched a public catalogue that contains information on supply shortages of medicines The catalogue includes information on medicine shortages affecting more than one Member State and that have been assessed by the Agency The aim of the catalogue is to offer a reference point for stakeholders for up to date information on shortages that have been assessed by the Agency The catalogue provides information on the reason of the shortage and the current status of the shortage ongoing or resolved information on the extent of the shortage specific information for patients and healthcare professionals links to relevant related documents Over the past few years there have been a number of public health crises caused by supply shortages of medicines as a result of manufacturing issues and good manufacturing practice GMP compliance problems Shortages can have important consequences for patients and healthcare professionals
53. tures the broad context of what s happening in science and medicine today and the role of the FDA as we enter the era of personalized medicine and for us personalized medical product development FDA commissioner Margaret A Hamburg MD said in a press briefing held at the FDA headquarters Monday Source Medscape amp Study questions FDA s shorter drug approval times Study authors Thomas Moore of the Institute for Safe Medication Practices and Dr Curt Furberg a professor at Wake Forest School of Medicine examined the development times clinical testing and risks associated with 20 new drugs approved in 2008 Eight were given expedited review and 12 standard review 24 It found that expedited drugs underwent a median of 5 1 years of clinical testing before being approved compared with 7 5 years for those that underwent a standard review But in many cases safety monitoring trials that were supposed to be conducted after the products were approved were either not conducted not completed or not submitted to the FDA Source Reuters FDA helps generic drugmakers get copies of Glaxo s Advair to market GlaxoSmithKline s asthma drug Advair is hard to copy The British pharma SGSK has said it time and again and recently generics giant Teva backed up that claim saying producing a generic would be too difficult before 2018 Some companies have given up on generic Advair while others have shied away altogether despite the sub
54. u comportement perturbateurs chez les patients atteints de maladie d Alzheimer ou de maladies apparent es publi es par la HAS en 2009 ont exclu les troubles du comportement d ficitaires ou de retrait telle que l apathie galement fr quente au cours de ces maladies L laboration de ces recommandations professionnelles entre dans le cadre du Plan Alzheimer 2008 2012 Source HAS amp HAS RAPPORT D EVALUATION TECHNOLOGIQUE Utilit clinique du dosage de la vitamine D source HAS E MIT ter r LAN S alt ta n La grr Prune iene Peele http www sante gouv fr comite economique des produits de sante ceps html Le a pres de 30 ans d exp rience et d expertise dans le domaine du RS incluant la maitrise de la m thodologie clinique La r daction de ces dossiers est un art complexe Les consequences pour les firmes peuvent tre cruciales Confiez nous vos dossiers de remboursement EUROPE htto www mhra gov uk amp MHRA Department of Health DOH appoints new Chair of the British Pharmacopoeia Commission Source MHRA 18 amp Antimicrobial prescribing and stewardship competencies The goal is to improve the quality of antimicrobial treatment and stewardship and so reduce the risks of inadequate inappropriate and ill effects of treatment This will improve the safety and quality of patient care and make a significant contribution to the reduction in the emergence and spread of antim
55. uters amp UEMOA UNION ECONOMIQUE ET MONETAIRE OUEST AFRICAINE http Www uemoa int Pages Home aspx REGLEMENT N 02 2005 CM UEMOA RELATIF A L HARMONISATION DE LA REGLEMENTATION PHARMACEUTIQUE DANS LES ETATS MEMBRES DE L UEMOA Source UEMOA 28 REGLEMENT N 06 2010 CM UEMOA RELATIF AUX PROCEDURES D HOMOLOGATION DES PRODUITS PHARMACEUTIQUES A USAGE HUMAIN DANS LES ETATS MEMBRES DE L UEMOA source UEMOA Fiscalit des m dicaments consommables et quipements m dicaux dans les pays membres de l UEMOA source Cerdi L Afrique de l Ouest des opportunit s d affaires d couvrir source SlideShare httos www dphm ci fr dom c C3 B4te divoire 3 L arr t N 297 MSP CAB DGS DPM du 13 DEC 2006 fixe l organisation les attributions et le fonctionnement de la Direction de la Pharmacie et du M dicament en abr g DPM conform ment au decr t N 2006 33 du 08 mars 2006 portant organisation du Minist re de la Sant et de l Hygi ne Publique La Direction de la Pharmacie et du M dicament en abr g DPM exer ant sous autorit de la Direction G n rale de la sant a pour missions d laborer de mettre en uvre et de veiller l application de la politique pharmaceutique nationale A ce titre elle est charg e De l laboration des projets de textes l gislatifs et r glementaires en mati re d enregistrement de m dicaments y compris des substances
56. varix according to new research The findings suggest that current HPV vaccination will be less beneficial for black women in the US than for their white counterparts said study coauthor Catherine Hoyo PhD MPH of Duke University in Durham North Carolina Source Medscape harmonisation for better health 4 _ P FZ EUROPE http www ich org http www picscheme or http www ipec europe or amp Summary of ICH Q3D Guideline for Elemental Impurities Draft Consensus Guideline Within scope New finished drug products as defined in ICH Q6A and Q6B and new drug products employing existing drug substances Drug products containing proteins and polypeptides produced from recombinant or non recombinant cell culture expression systems their derivatives and products of which they are components e g conjugates Drug products containing synthetically produced polypeptides polynucleotides and oligosaccharides aa i2ISummary_FDA Draft Guidance Q3D October 2013 pdf EUROPEAN UNION Submission of comments on Revision 4 of the Guideline on the format and content of application for designation as orphan medicinal and on its transfer from one sponsor to another ENTR 6283 00 Rev 4 and Revised Application form for orphan medicinal product designation Source EC Submission of comments on Guideline on the format and content of applications for designat
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